The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Endolight Led 1.1 Endolightled 1.2.
| Device ID | K121724 |
| 510k Number | K121724 |
| Device Name: | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Ron Haselhorst |
| Correspondent | Ron Haselhorst RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-12 |
| Decision Date | 2012-09-20 |
| Summary: | summary |